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Breaking! Japan Implements the New Japanese Standards of Quasi-drug Ingredients (JSQI 2021)

Japan introduced the new JSQI, new permitted quasi-drug additives list and new quasi-drug application rules on March 25, 2021. JSQI 2021 specifies 2,647 active quasi-drug ingredients and 84 test methods. The new permitted quasi-drug additives list deleted one ingredient, modified 13 ingredients’ name and made content corrections. The new quasi-drug application rules changed the previous requirements for the application for quasi-drugs manufacturing and marketing licenses.

On March 25, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) issued four documents, including the new Japanese Standards of Quasi-drug Ingredients (hereafter referred to as JSQI 2021), new List of Permitted Additives in Quasi-drugs, new Pre-market Application Rules of Quasi-drugs and a Collection of FAQs. In the above four documents, the ingredient standards are revised, and the corresponding pre-market application requirements of quasi-drug products are adjusted.

The four documents took effect on March 25, 2021. A grace period of 1.5 years until September 30, 2022 was granted to allow the industry to prepare for new compliance requirements. During the period, the previous quasi-drug ingredient standards and application rules still apply.

Compared with the existing regulations, the major revisions are as follows: 

1. Revisions to the JSQI

JSQI 2021 amended multiple ingredients and test methods in JSQI 2006, replacing it as a new overarching technical standard for quasi-drugs.

Items

Major Changes

Ingredients

1. Combines the original two attached active ingredient lists into one list, and sorts them according to the kana syllabary;

2. Modifies the specifications of 1453 ingredients;

3. Deletes the ingredient Ethanol (96). After the deletion, JSQI 2021 includes 2,647 ingredients.

 

* Note: After deleting Ethanol (96), “Ethanol” specified in JSQI 2021 only refers to “dehydrated ethanol" and "denatured alcohol".

Test methods

1. Adds two general test methods, bringing the total to 84;

2. Revises 17 test methods.

2. Revisions to the List of Permitted Additives in Quasi-Drugs

1. Change all the expressions of "JSQI 2006" in the previous additives list to "JSQI 2021";

2. Delete the ingredient No. 255 "Ethanol (96-96.5 degrees)" in the previous additives list. Notably, this ingredient can be considered as a permitted quasi-drug additive until September 30, 2022;

3. Clarify that the specification reference of ingredient No.1003 “Bis(Ethoxydiglycol) Cyclohexane-1,4-Dicarboxylate” shall be JSQI 2021 rather than Collections of Quasi-drugs Additives Standards;

4. Modify 13 additives’ English names in the previous additives list (see Table 1);

Previous Additive List

Current Additive List (2021 Version)

No.

Ingredients

No.

Ingredients

106

Alcailgenes Polysaccharides

106

Alcaligenes Polysaccharides

132

Althea Extract

132

Althaea Extract

161

Hestnut Rose Extract

161

Chestnut Rose Extract

283

Tetra (Polyoxyethylene Polyoxypropylene) Ethylene Diamine

282

Tetra(Polyoxyethylene/Polyoxypropylene) Ethylene Diamine

470

α-Olefine Oligomer

469

α-Olefin Oligomer

976

Neopentyl Glycol Di(2- Ethyl Hexanoate)

975

Neopentyl Glycol Di(2-Ethylhexanoate)

977

Di-2-Ethylhexylamine

976

Di(2- Ethylhexyl)amine(Dioc tylamine)

1396

Diglyceryl Sorbitan Tetra-2- Ethylhexanoate

1395

Diglyceryl Sorbitan Tetra(2- Ethylhexanoate)(Digly ceryl Sorbitan Tetraoctanoate)

1777

Grape Extact

1776

Grape Extract

2269

Mukurossi Peel Extract

2268

Mukorossi Peel Extract

2325

1,1'-Methylene-bis (4- isocyanatocyclohexane )Polypropylene Glycol Copolymer

2324

1,1'-Methylenebis(4- isocyanatocyclohexan e)Polypropylene Glycol Copolymer

2740

Romanchamomile Extract

2739

Roman Chamomile Extract

2745

Resin

2744

Rosin

Table 1 13 Renamed Additives

3. Revisions to the Pre-Market Application Requirements of the Quasi-Drugs

Along with the revisions to the quasi-drug ingredient standards, relevant application requirements for the manufacture and sale of quasi-drugs have been modified accordingly.

  • For quasi-drugs newly manufactured in line with JSQI 2021, applicants are required to write “JSQI (‘外原規’ in Japanese)” in the “Ingredient and Content” column in the application form, instead of filling in the specific specification of ingredients;

  • For quasi-drugs that contain any of the revised ingredients in JSQI 2021 and have already obtained a manufacturing or marketing license as per the old specifications, related companies shall apply for a slight modification to change the specific specification listed in the “Ingredient and Content” column to “JSQI (‘外原規’ in Japanese)”.

Notably, the obtained manufacturing and marketing licenses will remain valid until September 30, 2022. But starting from October 1, 2022, related companies shall comply with new application rules and re-apply for new manufacturing and marketing licenses.

4. FAQs about the Pre-Market Applications of Quasi-Drugs

To facilitate enterprises’ applications for the manufacture and sale of quasi-drugs, MHLW also released a FAQs collection, which includes 29 questions relating to the marketing/manufacturing approval of quasi-drugs/cosmetics, formula and test methods, etc.

Quasi-drug and cosmetic enterprises shall pay attention to the FAQ, and conduct business in line with the latest requirements.

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